A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 7, 2022

Primary Completion Date

May 25, 2022

Study Completion Date

May 25, 2022

Conditions
Pharmacokinetics
Interventions
DRUG

DFD-29 (Minocycline) Fasting

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

DRUG

DFD-29 (Minocycline) Fed

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.

DRUG

Solodyn (Minocycline) Fasting

In each study period, a single 105 mg dose of SOLODYN® Tablets will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

Trial Locations (1)

Unknown

CRO, Québec

All Listed Sponsors
collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

lead

Journey Medical Corporation

INDUSTRY

NCT05452785 - A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects | Biotech Hunter | Biotech Hunter